Is this your brand? Sign in to claim ownership.
Sign in to claim this brandEchopixel, Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 780 Montague Expy Ste 305, San Jose, CA, 95131
- Website
- echopixeltech.com
- —
- —
- [email protected]
- Phone
- 1-844-273-7766
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3011501361
- DUNS Number
- 079890297
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| True 3D Viewer | EP-00003 | FDA UDI | Class II | Active |
| Echo True 3d Viewer | K142107 | FDA 510(k) | Class II | Active |
| True 3D Viewer Software | K193149 | FDA 510(k) | Class II | Active |
| True 3D Viewer | K201365 | FDA 510(k) | Class II | Active |
| True 3D Viewer Software | K170167 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 21, 2018 | Z-1785-2025 | — | open, classified | With certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer, (for digital image processing/review/analysis/communication/media interchange acquired from CT/MRI/ultrasound, and pre-operative analysis of surgical options), can result in incorrect display of image orientation, which could result in misdiagnosis or incorrect surgical treatment plan. |
| Apr 11, 2016 | Z-1807-2025 | — | open, classified | Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior, inferior, anterior or posterior). This may lead to an inaccurate measurements. |